Associate Director, Pharmacovigilance Safety (Fixed-Term Contract)

3+ years

Not Disclosed

Bucharest

10 April 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director, Pharmacovigilance Safety (Fixed-term contract)
Date: Apr 9, 2025
Location: Bucharest, Romania, 050713
Company: Teva Pharmaceuticals
Job Id: 57908

Who we are
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development, and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

The opportunity
As an Associate Director, Pharmacovigilance Safety Physician, you will be responsible for conducting activities that determine the safety profile, monitor, and mitigate risks throughout the product lifecycle. You will provide comprehensive safety information to patients, prescribers, and regulators.

How you’ll spend your day

Accountable for the medical evaluation of aggregate safety data of assigned and non-assigned products, including signal detection, dose escalation evaluations, regulatory safety reports (PSUR, PADER, DSUR), and ad-hoc safety assessments (e.g., Health Hazard Assessments, abbreviated safety evaluations).
Review and evaluate complex Health Hazard Assessments and Health Authority requests.
Perform signal management activities, such as signal validation QC, authoring complex signal evaluations, and reviewing signal evaluations. Act as a medical reviewer to assess causality and consolidate safety data to determine whether a signal qualifies as a risk.
Support global risk management activities and contribute to Risk Management Plans (RMPs), REMS, and risk minimization measures throughout the product lifecycle.
Represent Pharmacovigilance (PV) in cross-functional teams, particularly in the Product Label Working Group, ensuring safety-related sections of the product label are evaluated and updated as needed.
Provide safety contributions to Health Authority submissions and responses, representing PV during product due diligence.
Collaborate effectively with internal and external stakeholders, including Medical Affairs, Clinical Development, Quality, KOLs, and CROs, to address safety concerns and ensure the overall safety profile of assigned products.

Your experience and qualifications

Medical Doctor degree.
Clinical practice experience and/or epidemiological training/degree.
At least 3 years of experience in pharmacovigilance and drug safety, particularly as a safety physician.
Proven ability to handle safety surveillance tasks and chair safety committee meetings.
Strong ability to serve as a subject matter expert.
Outstanding communication skills, with the ability to collaborate across departments and influence others without direct authority.
Ability to work cross-functionally within a matrix team, often across multiple time zones.
Oral and written fluency in English.

Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees.

Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. We are committed to a diverse and inclusive workplace for all.

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Associate Director, Pharmacovigilance Safety (Fixed-Term Contract)

Job Description

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